Phase 1 Study to Evaluate MEDI4736 in Participants with Myelodysplastic Syndrome
Study identifier:D4190C00007
ClinicalTrials.gov identifier:NCT02117219
EudraCT identifier:2014-000577-39
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1 Study to Evaluate the Safety and Tolerability of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with Myelodysplastic Syndrome after Treatment with Hypomethylating Agents
Medical condition
Myelodysplastic Syndrome
Phase
Phase 1
Healthy volunteers
No
Study drug
VIDAZA
Sex
All
Actual Enrollment
67
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 20 May 2014
Primary Completion Date: 30 Apr 2019
Study Completion Date: 30 Apr 2019
Study design
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2020 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Part 1: Durvalumab Dose 1 (Low/Intermediate 1) Participants with low/Intermediate-1 risk myelodysplastic syndrome (MDS) will receive intravenous (IV) infusion of durvalumab Dose 1 for protocol defined period or till disease progression, whichever occurs first. Participant who progress on durvalumab monotherapy will receive azacitidine as add-on therapy. | Biological/Vaccine: MEDI4736 Evaluate MEDI4736 in MDS MEDI4736 will be administered by IV infusion Other Name: durvalumab Drug: VIDAZA VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy Other Name: azacitidine |
| Experimental: Part 1: Durvalumab Dose 1 (Intermediate 2/High) Participants with intermediate 2/high risk MDS will receive IV infusion of durvalumab Dose 1 for protocol defined period or till disease progression, whichever occurs first. Participant who progress on durvalumab monotherapy will receive azacitidine as add-on therapy. | Biological/Vaccine: MEDI4736 Evaluate MEDI4736 in MDS MEDI4736 will be administered by IV infusion Other Name: durvalumab Drug: VIDAZA VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy Other Name: azacitidine |
| Experimental: Part 2: Durvalumab Dose 1 + Tremelimumab Dose 1 Participants with intermediate 2/high risk MDS will receive IV infusion of durvalumab Dose 1 in combination with tremelimumab Dose 1 for protocol defined period. Thereafter, participants will receive IV durvalumab Dose 1 monotherapy until the treatment discontinuation criteria meet. Participants who progress on durvalumab monotherapy, will be retreated with durvalumab and tremelimumab combination as mentioned above. | Biological/Vaccine: MEDI4736 Evaluate MEDI4736 in MDS MEDI4736 will be administered by IV infusion Other Name: durvalumab Biological/Vaccine: tremelimumab tremelimumab will be administered by IV infusion |
| Experimental: Part 2: Durvalumab Dose 1 + Tremelimumab Dose 2 Participants with intermediate 2/high risk MDS will receive IV infusion of durvalumab Dose 1 in combination with tremelimumab Dose 2 for protocol defined period. Thereafter, participants will receive IV durvalumab Dose 1 monotherapy until the treatment discontinuation criteria meet. Participants who progress on durvalumab monotherapy will be retreated with durvalumab and tremelimumab combination as mentioned above. | Biological/Vaccine: MEDI4736 Evaluate MEDI4736 in MDS MEDI4736 will be administered by IV infusion Other Name: durvalumab Biological/Vaccine: tremelimumab tremelimumab will be administered by IV infusion |
| Experimental: Part 2: Durvalumab Dose 1 + Tremelimumab Dose 2 + Azacitidine Participants with intermediate 2/high risk MDS will receive IV infusion of durvalumab Dose 1 in combination with tremelimumab Dose 2 and subcutaneous azacitidine for protocol defined period. Thereafter, participants will receive durvalumab Dose 1 in combination with azacitidine until the treatment discontinuation criteria meet. Participants who progress on durvalumab and azacitidine will be retreated with the durvalumab, tremelimumab, and azacitidine combination as mentioned above. | Biological/Vaccine: MEDI4736 Evaluate MEDI4736 in MDS MEDI4736 will be administered by IV infusion Other Name: durvalumab Drug: VIDAZA VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy Other Name: azacitidine Biological/Vaccine: tremelimumab tremelimumab will be administered by IV infusion |
Contacts
Investigators
Principal Investigator
MedImmune LLC
MedImmune
